Adult Tussin Cough and Chest Congestion DM

Product NDC
15127-384
11-digit product format
151270384
Labeler code
15127
Product ID
15127-384_02841a18-678a-4782-b9d9-779dc9c17419
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin
Dosage form
LIQUID
Route
ORAL
Labeler
Select Brand Dist.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-07-31
Marketing end
2020-12-31
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
10 mg/5mL; mg/5mL
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct15127-384DDiscontinued by firm2026-10-15
excluded packagepackage15127-38415127-384-04DDiscontinued by firm2026-10-15

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage15127-384-04d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage15127-384-04f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage15127-384-042ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage15127-384-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage15127-384-04cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage15127-384-04cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage15127-384-04302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage15127-384-04ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage15127-384-040efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage15127-384-04ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage15127-384-04367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage15127-384-04557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHADULT TUSSIN COUGH AND CHEST CONGESTION DM SUGAR FREE (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SELECT BRAND DIST.]1
GUAIFENESINACTIVE INGREDIENT495W7451VQADULT TUSSIN COUGH AND CHEST CONGESTION DM SUGAR FREE (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SELECT BRAND DIST.]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSADULT TUSSIN COUGH AND CHEST CONGESTION DM SUGAR FREE (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SELECT BRAND DIST.]1
GUAIFENESINACTIVE MOIETY495W7451VQADULT TUSSIN COUGH AND CHEST CONGESTION DM SUGAR FREE (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SELECT BRAND DIST.]1
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9ADULT TUSSIN COUGH AND CHEST CONGESTION DM SUGAR FREE (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SELECT BRAND DIST.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLADULT TUSSIN COUGH AND CHEST CONGESTION DM SUGAR FREE (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SELECT BRAND DIST.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXADULT TUSSIN COUGH AND CHEST CONGESTION DM SUGAR FREE (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SELECT BRAND DIST.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TADULT TUSSIN COUGH AND CHEST CONGESTION DM SUGAR FREE (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SELECT BRAND DIST.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AADULT TUSSIN COUGH AND CHEST CONGESTION DM SUGAR FREE (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SELECT BRAND DIST.]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EADULT TUSSIN COUGH AND CHEST CONGESTION DM SUGAR FREE (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SELECT BRAND DIST.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ADULT TUSSIN COUGH AND CHEST CONGESTION DM SUGAR FREE (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SELECT BRAND DIST.]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYADULT TUSSIN COUGH AND CHEST CONGESTION DM SUGAR FREE (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SELECT BRAND DIST.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUADULT TUSSIN COUGH AND CHEST CONGESTION DM SUGAR FREE (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SELECT BRAND DIST.]1
WATERINACTIVE INGREDIENT059QF0KO0RADULT TUSSIN COUGH AND CHEST CONGESTION DM SUGAR FREE (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SELECT BRAND DIST.]1